Compliance and Quality Specialist – IQVIA
IQVIA
Healthcare
Role Summary
The Local Compliance Specialist is responsible for ensuring quality and compliance in clinical trials by working with local and global quality functions. The role involves monitoring compliance risk, supporting audits and inspections, managing procedures, and providing guidance on regulatory and quality-related matters.
Job Description
The Local Compliance Specialist is responsible for ensuring a comprehensive quality and compliance approach for clinical trials in collaboration with the sponsor's local and global quality functions. The role involves monitoring compliance risk, performing quality control checks, supporting audits and inspections, managing local procedures, and providing expertise and guidance on SOP, system, GCP questions, and regulatory intelligence.
Job Requirements
BA/BS degree in a health or science related field.
3 years of previous Pharmaceutical Industry experience with 2 years of experience within clinical research and development and/or quality assurance.
Knowledge of the overall drug development process.
Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset.
Conflict resolution/management and negotiation skills.
Excellent working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development.
Experience with regulatory submissions is an asset.
Experience in R&D process requirements to successfully drive Compliance productivity, strategy optimization, process improvements and efficiencies including development and management of CAPA and facilitation of Root Cause Analysis.
Demonstrated project leadership skills.
Problem solver, strategic thinker, leader and collaborator.
Highly committed to quality and compliance.
Possess excellent written, oral communication, interpersonal skills, diplomacy, and presentation skills and outstanding customer service.
Quick Info
Company
IQVIA
Location
Kuala Lumpur
Salary
Undisclosed
Skills Required
10 skills
Click to submit your application
Required Skills
Clinical Research
Quality Assurance
Regulatory Compliance
FDA/ICH Guidelines
Audit Management
Conflict Resolution
Project Leadership
Root Cause Analysis
CAPA Development
Communication Skills
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